腫瘍向けコンパニオン診断：グローバル市場分析と予測...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 6
1.1 List of Tables 12
1.2 List of Figures 23
2 Introduction 28
2.1 Catalyst 28
2.2 Related Reports 29
3 Industry Overview 30
3.1 Emergence of Companion Diagnostics 30
3.1.1 Definition of Companion Diagnostics 30
3.1.2 Changing Face of Medicine 31
3.1.3 Definitions of Companion and Personalized Diagnostics 33
3.2 Disease Applications 35
3.2.1 Breast Cancer 35
3.2.2 Colorectal Cancer 38
3.2.3 Melanoma 40
3.2.4 Non-Small Cell Lung Cancer 41
3.3 Companion Diagnostics Technologies 43
3.3.1 Immunochemical Techniques 43
3.3.2 Nucleic Acid Testing 45
3.3.3 Emerging Technologies 52
3.4 Companion Diagnostics Development 54
3.4.1 Economic Value of a Companion Diagnostic 54
3.4.2 When to Develop a Companion Diagnostic Test 55
3.4.3 Strategy 58
3.4.4 Selection of Partner 59
3.4.5 Biomarker Discovery 61
3.5 Clinical Outcomes 62
3.5.1 Role of Companion Diagnostics in Disease Treatment 62
3.5.2 Companion Diagnostic Test Applications 63
3.6 Testing Trends 64
3.6.1 US 64
3.6.2 France 75
3.6.3 Germany 85
3.6.4 Italy 92
3.6.5 Spain 100
3.6.6 UK 106
3.6.7 Japan 120
3.6.8 Brazil 129
3.6.9 China 135
3.6.10 India 143
3.7 Market Access 150
3.7.1 Overview 150
3.7.2 US 150
3.7.3 5EU 154
3.7.4 Japan 165
3.7.5 Brazil 167
3.7.6 China 169
3.7.7 India 172
3.8 Regulatory Issues and Recalls 173
3.8.1 Dako FDA Warning Letter 173
3.8.2 HercepTest Recall 174
3.8.3 Cobas KRAS Test Recall 174
3.8.4 Cobas BRF V600E Test Recall 174
3.8.5 Leica Bond HER2 IHC System 174
3.9 Reimbursement of Companion Diagnostic Tests 175
3.9.1 US 175
3.9.2 Europe 180
3.9.3 APAC 192
3.9.4 South America 197
3.10 M&A, Key Partnerships 199
3.10.1 Significant Mergers and Acquisitions 201
3.10.2 Recent Partnerships 201
3.11 Economic Impact 207
3.11.1 Cost Effectiveness of Companion Diagnostics 207
3.11.2 Cost Effectiveness of Companion Diagnostics: Healthcare Provider Perspective 208
3.12 Market Drivers 214
3.12.1 Driver: Increasing Healthcare Pressures 214
3.12.2 Driver: Adverse Economic Pressures 215
3.12.3 Driver: Availability of New Technologies 215
3.12.4 Driver: FDA Regulatory Changes 216
3.12.5 Driver: Need to Improve Drug Development Processes 216
3.12.6 Driver: Increasing Cancer Incidence 217
3.12.7 Driver: Accelerating Demand for Targeted Therapies 217
3.13 Market Barriers 219
3.13.1 Barrier: Reimbursement Difficulties 219
3.13.2 Barrier: Loss of Indication 219
3.13.3 Barrier: Emergence of Biosimilar Therapies 220
3.13.4 Barrier: Competition with Laboratory-Developed Tests 221
3.13.5 Barrier: Emergence of Next-Generation Gene Sequencing 222
3.13.6 Barrier: Lack of Laboratory Choice in Instrument Selection 223
3.13.7 Barrier: Lack of Patient Awareness about Companion Diagnostic Tests 224
3.13.8 Barrier: Physician Resistance to New Companion Diagnostic Tests 225
4 Competitive Assessment 227
4.1 Overview 227
4.2 Techniques in Use by Currently Marketed Products 227
4.2.1 Immunohistochemistry 227
4.2.2 Fluorescence In Situ Hybridization 227
4.2.3 Polymerase Chain Reaction 228
4.3 Competitive Analysis 228
4.3.1 Breast Cancer Companion Diagnostic Tests 228
4.3.2 Colorectal Cancer Companion Diagnostic Tests 257
4.3.3 Melanoma Companion Diagnostic Tests 267
4.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 273
5 Unmet Needs 290
5.1 Need for Improved Cancer Treatments 290
5.2 Need for Objective Tests 290
5.3 Need for High-Throughput Tests 292
5.4 Certainty of Reimbursement 293
5.5 Amount and Type of Tissue Needed for Test 294
5.6 Who Should be Tested? 297
5.7 Test Accuracy 302
5.8 Increasing Test Complexity and Increased Process Failure 305
6 Pipeline Products 306
6.1 Overview 306
6.2 Pipeline by Phase of Development 308
6.3 Pipeline Product Profiles 310
6.3.1 Breast Cancer Companion Diagnostic Tests 310
6.3.2 Colorectal Cancer Companion Diagnostic Tests 318
6.3.3 Melanoma Companion Diagnostic Tests 324
6.3.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 331
7 Clinical Trials to Watch 347
7.1 Overview 347
7.2 Key Clinical Trials Utilizing Pipeline Companion Diagnostic Tests Linked to Specific Drug Therapies 351
8 Current and Future Players 352
8.1 Trends in Corporate Strategy 352
8.1.1 Companion Diagnostics Business Models 352
8.2 Company Profiles 353
8.2.1 Pharmaceutical/Therapy Companies Developing Companion Diagnostic Tests 353
8.2.2 Diagnostics Companies Developing Companion Diagnostic Tests (in Partnership with Pharmaceutical Companies) 409
9 Market Outlooks 492
9.1 By Market Segment 492
9.1.1 Breast Cancer Companion Diagnostic Tests 492
9.1.2 Colorectal Cancer Companion Diagnostic Tests 493
9.1.3 Melanoma Companion Diagnostic Tests 496
9.1.4 Non-Small Cell Lung Cancer Companion Diagnostic Tests 498
9.1.5 Technique 504
9.2 By Geography 507
9.2.1 10 Major Markets Overview 507
9.2.2 US 509
9.2.3 France 510
9.2.4 Germany 512
9.2.5 Italy 514
9.2.6 Spain 516
9.2.7 UK 518
9.2.8 Japan 520
9.2.9 Brazil 523
9.2.10 China 525
9.2.11 India 527
10 Appendix 530
10.1 Bibliography 530
10.2 Abbreviations 582
10.3 Report Methodology 584
10.3.1 Coverage 584
10.3.2 Secondary Research 585
10.3.3 Forecasting Methodology 585
10.4 Physicians Included in this Study 587
10.5 About the Authors 589
10.5.1 Andrew Thompson, Ph.D., Senior Analyst, In Vitro Diagnostics 589
10.5.2 Derek Archila, MBA, Lead Analyst, Medical Devices 589
10.5.3 Bonnie Bain, PhD, Global Head of Healthcare 590
10.6 Disclaimer 591